Label: BACMIN- vitamin a acetate, .alpha.-tocopherol acetate, ascorbic acid, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, biotin, calcium pantothenate, folic acid, cyanocobalamin, flavone, ferrous fumarate, chromic chloride cr-51, magnesium oxide, manganese gluconate, cupric oxide, selenomethionine, and zinc oxide tablet, coated

  • NDC Code(s): 0682-3001-01
  • Packager: Marnel Pharmaceuticals, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated May 2, 2014

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Vitamin/Mineral Nutritional Supplement
    Rx ONLY

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  • DESCRIPTION

    Each BACMIN caplet contains:

    Quantity
    Fat-Soluble Vitamins
    Vitamin A (vitamin A acetate) 2000 IU
    Vitamin E (d-alpha tocopheryl acetate) 30 IU
    Water-Soluble Vitamins
    Vitamin C (ascorbic acid) 500 mg
    Vitamin B1 (thiamine mononitrate) 20 mg
    Vitamin B2 (riboflavin) 20 mg
    Niacin (niacinamide) 100 mg
    Vitamin B6 (pyridoxine HCl) 25 mg
    Biotin 150 mcg
    Pantothenic acid (D-calcium pantothenate) 25 mg
    Folic acid 1.0 mg
    Vitamin B12 (cyanocobalamin) 50 mcg
    Lemon Bioflavonoids 50 mg
    Minerals
    Iron (ferrous fumarate) 27 mg
    Chromium (chromium chloride) 0.1 mg
    Magnesium (magnesium oxide) 50 mg
    Manganese (manganese gluconate) 5 mg
    Copper (cupric oxide) 3 mg
    Selenium (L-selenomethionine) 50 mcg
    Zinc (zinc oxide) 22.5 mg
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  • DESCRIPTION

    BACMIN is a prescription-only oral multivitamin/mineral caplet specially formulated for prophylactic or therapeutic nutritional supplementation in physiologically stressful conditions.

    BACMIN supplies: therapeutic levels of water-soluble vitamins (ascorbic acid and all B-complex vitamins except biotin); supplemental levels of biotin, fat-soluble vitamins (A and E) and minerals (iron, chromium, manganese, copper, selenium and zinc); plus magnesium.

    Inactive ingredients: microcrystalline cellulose, silicon dioxide, stearic acid, croscarmellose sodium and magnesium stearate. Coating contains: hydroxypropyl methylcellulose, maltodextrin, hydroxypropyl cellulose, FD&C red No. 40 aluminum lake, triacetin, titanium dioxide, polyethylene glycol, FD&C blue No. 1 aluminum lake.

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  • INDICATIONS

    BACMIN is indicated for prophylactic or therapeutic nutritional supplementation in physiologically stressful conditions. These include:

    Conditions causing depletion, reduced absorption or bioavailability of essential vitamins and minerals-

    • Inadequate intake due to highly restricted or unbalanced diets such as those frequently associated with anorexic conditions and other states of severe malnutrition.
    • Gastrointestinal disorders, chronic alcoholism, chronic or acute infections (especially those involving febrile illness), prolonged or wasting disease, congestive heart failure, hyperthyroidism, poorly controlled diabetes or other physiologic stress.
    • Also, patients on estrogenic oral contraceptives or other estrogen therapy, anti-bacterials which affect intestinal microflora, or other interfering drugs.

    Certain conditions resulting from severe B-Vitamin or ascorbic acid deficiency-

    • Recovery from surgery or trauma involving severe burns, fractures or other extensive tissue damage.
    • Also, pregnant women and those with heavy menstrual bleeding.
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  • CONTRAINDICATIONS

    BACMIN is contraindicated in patients hypersensitive to any of its components.

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  • WARNINGS

    Not intended for treatment of pernicious anemia or other megaloblastic anemias where vitamin B12 is deficient. Neurological involvement may develop or progress, despite temporary remission of anemia, in patients with vitamin B12 deficiency who receive supplemental folic acid and who are inadequately treated with B12.

    Drug and Treatment Interactions

    As little as 5 mg pyridoxine daily can decrease the efficiency of levodopa in the treatment of parkinsonism. Therefore, BACMIN is not recommended for patients undergoing such therapy.

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  • ADVERSE REACTIONS

    Adverse reactions have been reported with specific vitamins and minerals, but generally at levels substantially higher than those in BACMIN. However, allergic and idiosyncratic reactions are possible at lower levels. Iron, even at the usual recommended levels, has been associated with gastrointestinal intolerance in some patients.

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  • DOSAGE AND ADMINISTRATION

    Usual adult dosage: one caplet daily.

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  • HOW SUPPLIED

    Dark red caplets. Bottles of 30, NDC 0682-3001-30. Bottles of 100, NDC 0682-3001-01.

    Sample envelope - 2 caplets- NDC 0682-3001-02.

    Imprint MMD on top with plain lower.

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  • SPL UNCLASSIFIED SECTION

    Manufactured for:
    Marnel Pharmaceuticals,
    Lafayette, LA 70506

    Manufactured by:
    Nexgen Pharma, Inc.,
    Irvine, CA 92614

    6381
    Rev. 08/07B

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  • PRINCIPAL DISPLAY PANEL - 100 Caplet Bottle Label

    MARNEL

    NDC 0682-3001-01

    BACMIN
    CAPLETS
    VITAMIN/MINERAL NUTRITIONAL
    SUPPLEMENT

    Rx ONLY

    100 CAPLETS

    Manufactured for:
    MARNEL PHARMACEUTICALS, INC.
    Lafayette, Louisiana 70506

    PRINCIPAL DISPLAY PANEL - 100 Caplet Bottle Label
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  • INGREDIENTS AND APPEARANCE
    BACMIN 
    vitamin a acetate, .alpha.-tocopherol acetate, ascorbic acid, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, biotin, calcium pantothenate, folic acid, cyanocobalamin, flavone, ferrous fumarate, chromic chloride cr-51, magnesium oxide, manganese gluconate, cupric oxide, selenomethionine, and zinc oxide tablet, coated
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0682-3001
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A 2000 [iU]
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL ACETATE 30 [iU]
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 500 mg
    THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE 20 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 20 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 100 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE 25 mg
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN 150 ug
    CALCIUM PANTOTHENATE (UNII: 568ET80C3D) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID 25 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 50 ug
    FLAVONE (UNII: S2V45N7G3B) (FLAVONE - UNII:S2V45N7G3B) FLAVONE 50 mg
    FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 27 mg
    CHROMIC CHLORIDE CR-51 (UNII: U4M5Y13FGM) (CHROMIUM CR-51 - UNII:9QAU17N705) CHROMIC CHLORIDE CR-51 0.1 mg
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE 50 mg
    MANGANESE GLUCONATE (UNII: 9YY2F980SV) (MANGANESE CATION (2+) - UNII:H6EP7W5457) MANGANESE GLUCONATE 5 mg
    CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION 3 mg
    SELENOMETHIONINE (UNII: 964MRK2PEL) (SELENOMETHIONINE - UNII:964MRK2PEL) SELENOMETHIONINE 50 ug
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 22.5 mg
    Inactive Ingredients
    Ingredient Name Strength
    cellulose, microcrystalline (UNII: OP1R32D61U)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    stearic acid (UNII: 4ELV7Z65AP)  
    croscarmellose sodium (UNII: M28OL1HH48)  
    magnesium stearate (UNII: 70097M6I30)  
    hypromelloses (UNII: 3NXW29V3WO)  
    maltodextrin (UNII: 7CVR7L4A2D)  
    hydroxypropyl cellulose (type h) (UNII: RFW2ET671P)  
    FD&C red No. 40 (UNII: WZB9127XOA)  
    aluminum oxide (UNII: LMI26O6933)  
    triacetin (UNII: XHX3C3X673)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    polyethylene glycols (UNII: 3WJQ0SDW1A)  
    FD&C blue No. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    Color RED (Dark Red) Score no score
    Shape OVAL Size 19mm
    Flavor Imprint Code MMD
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0682-3001-01 100 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 04/01/2000
    Labeler - Marnel Pharmaceuticals, Inc. (053781795)
    Establishment
    Name Address ID/FEI Business Operations
    Nexgen Pharma, Inc. 160356114 MANUFACTURE(0682-3001)
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